Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO) (VIBRANT)
Branch Retinal Vein Occlusion
About this trial
This is an interventional treatment trial for Branch Retinal Vein Occlusion
Eligibility Criteria
Inclusion Criteria:
The following inclusion criteria include, but are not limited to:
- Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit
- ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1
- Provide signed informed consent
Exclusion Criteria:
The following exclusion criteria include, but are not limited to:
- Current bilateral manifestation of BRVO
- Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye
- Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves)
- Uncontrolled diabetes mellitus (DM)
- Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye
- Use of periocular corticosteroids in the study eye within 3 months before day 1
- Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1
- Previous administration of systemic anti-angiogenic medications
- Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Macular Laser Photocoagulation Treatment (Control)
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Participants will receive macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants will receive treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
Participants will receive 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group may receive laser rescue at week 36.